MICROSONIC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-02 for MICROSONIC * manufactured by Microsonic.

Event Text Entries

[86930] A 5 yr old female was referred to audiology for a hearing exam on november 11, 1997. It was determined that she had a hearing loss in both ears and it was decided to take molds in order to fit her for the hearing aids. The audiologist mixed the ingredients, which are premeasured, and having placed a foam block into the pt's right ear, proceeded to pour the mixture into that ear. A few mins later, she did the left ear, following the same procedure. She removed the mold from the right ear approx five to ten mins later and it came right out, with the plug attached. She then removed the mold from the left ear after the appropriate length of time, and it too came right out with the plug attached. After examining the mold, she realized that it was not formed properly and she would have to redo the left ear. A new plug was placed in the ear, a new mixture was made and inserted into the left ear. When the mold had set up, she loosened it and started to pull it out. The pt began screaming. She noted there was some resistance while she was pulling on it. The pt was taken to an ent physician who was able to pull it out. However, the plug and string remained in the ear. When the physician pulled on the string, it came out, but the plug remained in. The physician noted there was mold material left in her ear and attempted to remove it but was unsuccessful. The pt was brought back to the or on november 12 and under anesthesia, approx twenty small pieces of mold material were removed. However, there was residual polymer left in the ear. On november 20, she underwent further lengthy surgery and the surgeon was unable to remove all of the material in her ear and he noted there was damage to the middle ear. She has sustained further hearing loss in her left ear. She will have to undergo further reconstructive surgery at a later date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number153321
MDR Report Key153321
Date Received1998-02-02
Date of Report1997-12-11
Date of Event1997-11-11
Date Facility Aware1997-11-11
Report Date1997-12-11
Date Added to Maude1998-03-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMICROSONIC
Generic NameEARMOLD
Product CodeLDG
Date Received1998-02-02
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key149372
ManufacturerMICROSONIC
Manufacturer Address1421 MERCHANT ST. AMBRIDGE PA 15003 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1998-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.